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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K980656
Device Name PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact ROBERT L WILSINSON
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact ROBERT L WILSINSON
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/19/1998
Decision Date 05/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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